483
Prescient Surgical, Inc.Prescient Surgical, Inc. – FDA 483, Jul 19, 2019
Record Details
Prescient Surgical, Inc. in San Carlos, CA, a medical device manufacturer, was cited with three observations during an FDA inspection. The inspection revealed deficiencies in process validation, design control procedures, and documentation of acceptance activities, indicating a need for improved quality system controls.
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ID · f7304a6c-7791-4726-90b4-8ff52c980011
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